News and updates on potential cures for type-1 diabetes, that are in human (or clinical) trials.

Wednesday, February 17, 2010

Diamyd Combo Phase-II Trial Scaled Back

Back in Feburary 2009 I blogged on a very promising clinical trail that was combining the Diamyd treatment to stop the autoimmune attack and two drugs which were already approved for use in the USA. This is an update for that research.

Diamyd Combo Phase-II Trial Scaled Back

This Phase II study combines regenerative agents (lansoprazole and sitagliptin) and Diamyd. The regenerative agents are both marketed drugs in the US. Diamyd is a vaccine like drug which trains the body's autoimmune system not to attack it's own cells. Sitagliptin (Januvia) is a dipeptidyl peptidase-4 (DPP-4) inhibitor, and is used for type-2 diabetes. Lansoprazole (Prevacid) is a proton-pump inhibitor (PPI) which prevents the stomach from producing gastric acid. The researchers hope that both lansoprazole and sitagliptin will help reverse beta cell damage or develop new beta cells.

This trial has been scaled back is a big way. Originally, the researchers were hoping to screen about 160 people and include about 80 of them in the trial. However, just after the study enrolled it's first patient, there was a major funding cut at NIH (the part of the US government were the study was being done). At the same time, the primary investigator (Dr. David Harlan) got a new job at UMass at Worster, and so left NIH. This double setback caused the study to shrink and be redesigned.

Instead of 80 people in a placebo controlled, randomized trial, they ended up with 3 people in a pilot study where everyone was treated (so no control group). Now the good news is that the trial is fully enrolled, so they will have all their data by October 2012. However, the bad news is that the results will be hard to interpret (maybe impossible). Because this study is using honeymoon type-1 diabetics, there is natural fluctuation in the amount of insulin used. So with only 3 people and no control group, it will be hard to tell if any improvements are caused by the treatment or random fluctuation during the honeymoon.

Some Personal Opinions

Obviously, I'm hopeful that Dr. Harlan will restart this experiment once he gets settled at UMass Worster. As far as I know this is the only clinical trail combining a treatment to control the autoimmune attack and a treatment to help the body generate more insulin. I think combination like this represent one very promising approach to a future cure to type-1 diabetes. It's very disappointing to have it scaled back so much, and for reasons so unrelated to safety or effectiveness.

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This blog discusses cures and preventatives for type-1 diabetes that are either in human trials or just about to start. Treatments for diabetes are not generally discussed here, unless they can turn into a cure or a preventative. My definition of a cure is this:1. Blood sugar control without testing and with doctor's visits 4 times a year, or less. Any cure must result in an average lifespan close to normal.2. Does not require a lifetime of immunsuppressive drugs, so it is not trading one treatment for another. (but a couple of operations, or a short course of drugs is OK)Obviously, this is my personal definition of a cure; yours may differ.Because a cure for type-1 diabetes is likely to involve a combination of several different drugs or treatments, I try to follow research into anything which may be an important part of the cure.

My Non-Conflict of Interest Statement

For the first 10 years of running this blog, I did not work for a company doing medical research. In 2018, I started working for Bigfoot Biomedical, which is developing an "automated insulin dosing/delivery solution" (what many call an Artificial Pancreas).

I blog on research aimed at curing type-1 diabetes, and I view Bigfoot Biomedical's work as treating type-1 diabetes (not a cure at all). Therefore, I don't view this work as conflicting with my blogging. However, if you consider the kind of automated insulin dosing/delivery solution that Bigfoot is developing to be an actual cure for type-1, then this would conflict with my blogging. I think they are quite different.

I don't get paid in any way by any company working on a cure for type-1 diabetes; I never have. And that includes free samples, free travel, or free anything. I do sometimes participate in market research studies or focus groups, and they sometimes pay.

None of the hours that I have put into my blog, or the posts that I make to any web site, has ever been paid for. (Except for some very nice and heart felt thank-you emails, and those are worth more than money.)

My daughter has type-1 diabetes and participates in clinical trials. I sometimes report on trials that she participates in, but I do not reveal her participation because I consider her medical history to be private.

I sometimes "beta test" new software or devices involved in type-1 diabetes. When I'm blogging about something where I have been given special access, I say so.

In the past I have volunteered with JDRF and The NIIB Project. I currently am a fellow with JDCA. The JDRF and NIIB work was completely unpaid. JDCA has given me equipment that I use to help my blogging, and on one occasion paid for specific consulting work.